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Boletín Médico del Hospital Infantil de México

2009, Número 3

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Bol Med Hosp Infant Mex 2009; 66 (3)


Importancia de la farmacovigilancia en pediatría.

Jasso-Gutiérrez L, Castellanos-Solís EC, Santos-Preciado JI

Idioma: Español
Referencias bibliográficas: 57
Paginas: 213-228
Archivo PDF: 167.59 Kb.


RESUMEN

Con el objetivo de destacar la importancia de la farmacovigilancia en pediatría, se efectuó una revisión con especial énfasis en sus aspectos generales y conceptuales, sustentados en la Norma Oficial Mexicana y otras. Se describen las diferentes clasificaciones de las Reacciones Adversas a los Medicamentos (RAM) y de los Eventos Adversos a los Medicamentos (EAM). Utilizando como fuente la base de datos del Centro de Monitoreo Internacional de los Medicamentos, en la que se analiza hasta el año 2006 el estado actual de los reportes de las RAM de 82 países, en el que México se ubica, por grupos de edad y por número de reportes, en un lugar intermedio con el resto de los países. Se destaca el impacto de las RAM en la población general en aspectos de morbilidad, mortalidad, secuelas y economía. Se comunican las experiencias de grupos internacionales sobre el impacto de los EAM y las RAM en la edad pediátrica y neonatal. Se mencionan varias recomendaciones que permitirán que en México se implante o mejore un sistema de farmacovigilancia en los niños, en el que el Hospital Infantil de México Federico Gómez ha iniciado un ambicioso programa.


REFERENCIAS (EN ESTE ARTÍCULO)

  1. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnes C, Hernández-Santillán D, Jasso-Gutiérrez L. Farmacovigilancia I. El inicio. Rev Med IMSS. 2004; 42: 327-9.

  2. FDA. Adverse Event Reporting System (AERS). Available at: http://www.fda.gov/cder/aers/default.htm. Accessed January 29, 2008.

  3. McDonnell PJ. Turning adverse drug events into better patient care. http://www.medscape.com/viewarticle/569872. Accessed february 29, 2008.

  4. Norma Oficial Mexicana NOM-220-SSA1-2002, Instalación y operación de la farmacovigilancia. DOF. Lunes 15 de noviembre, 2004. http://www.salud.gob.mx/unidades/cdi/nom/220ssa102.html. Acceso, febrero, 28, 2008.

  5. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnes C, Hernández-Santillán D, Jasso-Gutiérrez L. Farmacovigilancia II. Las reacciones adversas y el Programa Internacional de Monitoreo de los Medicamentos. Rev Med IMSS. 2004; 42: 419-23.

  6. Leape L. A systems analysis approach to medical error. En: Cohen M, editor. Medication error. Washington, DC: Americal Pharmaceutical Association; 1999: p. 21.

  7. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnes C, Hernández-Santillán D, Jasso-Gutiérrez L. Farmacovigilancia III. La experiencia internacional. Rev Med IMSS. 2005; 43: 131-40.

  8. Rawlins MD, Thompson JW. Pathogenesis of adverse drug reaction. En: Davies DM, editor. Davie ’s Textbook of adverse drug reaction. New York, EUA: Oxford University Press; 1977. p. 44.

  9. Meyboom RHB, Lindquist M, Egberts AAC. An ABC of drugs related problems. Drug Saf. 2000; 22: 416-23.

  10. Norma que Establece las Disposiciones para la Operación del Sistema Institucional de Farmacovigilancia y la Vigilancia de Insumos para la Salud en el Instituto Mexicano del Seguro Social. http://www.imss.gob.mx/cuadrosbasicos/farmaco%2Dvigilancia/index_archivos/norma.htm#1. Acceso, febrero 15, 2008.

  11. Olsson S. Chief WHO Programme Officer. Manager External Affaire. The Uppsala Monitoring Centre. Uppsala, Sweden (Comunicación personal).

  12. Begaud B, Martin K, Fourrier A, Haramburu F. Does age increase the risk of adverse drug reactions? Br J Clin Pharmacol. 2002; 54: 550-2.

  13. Starfield B. Is US health really the best in the World? JAMA. 2000; 284: 483-5.

  14. Johnson JA, Bootman JL. Drug-related morbidity and mortality: A cost-of-illness model. Arch Intern Med. 1995; 155: 1949-56.

  15. Ross SD. Drug-related adverse events: A readers’ guide to assessing literature reviews and meta-analyses. Arch Intern Med. 2001; 161: 1041-6.

  16. Kohn LT, Corrigan JM, Donaldson MS. To err is human: Building a safer health system. Executive Summary Report of the Institute of Medicine. Washington, DC: National Academy Press; 1999.

  17. Temple ME, Robinson RF, Millar JC, Hayes JR, Nahata MC. Frequency and preventability of adverse drug reactions in paediatric patients. Drug Saf. 2004; 27: 819-29.

  18. WHO. International drug monitoring: The role of the hospital. WHO Tech Rep Ser. 1969; 426: 5-24.

  19. Budnitz DS, Pollack DA, Weidenbach KN. National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006; 296: 1858-66.

  20. McDonnell PJ, Jacobs MR. Hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother. 2002; 36: 1331-6.

  21. Wilson T. Medical errors. System for reporting errors is not highest priority to decrease errors. BMJ. 2001; 322: 1421-2.

  22. Woods DM, Thomas EJ, Holl JL, Weiss KB, Brennan TA. Ambulatory care adverse events and preventable adverse events leading to a hospital admission. Qual Saf Health Care. 2007; 16: 127-31.

  23. Morris LA. The risk revolution: An examination of the regulatory environment. JAPHA. 2001; 41 Suppl 1: S5-10.

  24. Cohen AL, Budnitz DS, Weidenbach KN, Jernigan DB, Schroeder TJ, Shehab N, et al. National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. J Pediatr. 2008; 152: 416-21.

  25. Kimland E, Rane A, Ufer M, Panagiotidis G. Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharmacoepidemiol Drug Saf. 2005; 14: 493-9.

  26. Le J, Nguyen T, Law AV, Hodding J. Adverse drug reactions among children over a 10-year period. Pediatrics. 2006; 118: 555-62.

  27. Kimland E, Bergman U, Lindemalm S, Bottiger Y. Drug related problems and off-label drug treatment in children as seen at a drug information centre. Eur J Pediatr. 2007; 166: 527-32.

  28. Neubert A, Dormann H, Weiss J. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf. 2004; 27: 1059-67.

  29. Jong GW, Eland IA, Sturkenboom MC, van den Anker JN, Stricker BH. Determinants for drug prescribing to children below the minimum licensed age. Eur J Clin Pharmacol. 2003; 58: 701-5.

  30. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: A prospective study. Acta Paediatr. 1999; 88: 965-8.

  31. Hill P. Off licence and off label prescribing in children: litigation fears for physicians. Arch Dis Child. 2005; 90 Supl 1: i17-8.

  32. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002; 54: 665-70.

  33. Dos Santos DB, Coelho HL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiol Drug Saf. 2006; 15: 635-40.

  34. Jonville-Béra AP, Giraudeau B, Blanc P, Beau-Salinas F, Autret-Leca E. Frequency of adverse drug reactions in children: A prospective study. Br J Clin Pharmacol. 2002; 53: 207-10.

  35. Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse events from cough and cold medications in children. Pediatrics. 2008; Jan 30 [Epub ahead of print].

  36. Zandieh SO, Goldmann DA, Kechane CA, Yoon C, Bates DW, CaEUAl R. Risk factors in preventable adverse drug event in pediatric outpatients. J Pediatr. 2008; 152: 225-31.

  37. Lavalle-Villalobos A, Payro-Cheng TJ, Martínez-Cervantes KA, Torres-Narváez P, Hernández-Delgado L, Flores-Nava G. El error médico en la prescripción de medicamentos y el impacto de una intervención educativa. Bol Med Hosp Infant Mex. 2007; 64: 83-90.

  38. Miller MR, Robinson KA, Lubomnski LH, Rinde ML, Pronovost PJ. Medication errors in paediatric care: A systematic review of epidemiology and an evaluation of evidence supporting reduction strategy recommendations. Qual Safe Health Care. 2007; 16: 116-26.

  39. Van den Anker JN. Managing drugs safely. Semin Fetal Neonatal Med. 2005; 10: 73-81.

  40. Lenclen R. Medication errors in neonatology: A review. Arch Pediatr. 2007; 14 Supl 1: S71-7.

  41. Simpson JH, Lynch R, Grant J, Alroomi L. Reducing medication errors in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2004; 89: F480-2.

  42. Dell’Aera M, Gasbarro AR, Padovano M, Laforgia N, Capodiferro D, Solarino B, et al. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci. 2007; 29: 361-7.

  43. Chedoe I, Molendijk HA, Dittrich ST, Jansman FG, Harting JW, Brouwers JR, et al. Incidence and nature of medication errors in neonatal intensive care with strategies to improve safety: A review of the current literature. Drug Saf. 2007; 30: 503-13.

  44. Ligi I, Arnaud F, Jouve E, Tardieu S, Sambuc R, Simeoni U. Iatrogenic events in admitted neonates: A prospective cohort study. Lancet. 2008; 371: 404-10.

  45. Vallejos A. Adverse reactions by antibiotics in a pediatric and neonatal intensive care unit located in Bogotá, Colombia. Biomedica. 2007; 27: 66-75.

  46. Clark RH, Bloom BT, Spitezer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: Data from a large national data set. Pediatrics. 2006; 117: 1979-87.

  47. Anderson PO, Pochop SL, Manoguerra AS. Adverse drug reactions in breastfed infants: Less than imagined. Clin Pediatr (Phila). 2003; 42: 325-40.

  48. Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics. 2002; 110: e53.

  49. Du W, Warrier I, Tutag-Lehr V, Salari V, Ostrea E, Aranda JV. Changing patterns of drug utilization in a neonatal intensive care population. Am J Perinatol. 2006; 23: 279-85.

  50. Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety. Expert Opin Drug Saf. 2006; 5: 703-18.

  51. Kumar P, Walker JK, Hurt KM, Bennett KM, Grosshans N, Fotis MA. Medications use in the neonatal intensive care unit: Current patterns and off-label use of parenteral medications. J Pediatr. 2008; 152; 412-5.

  52. Leonard MS, Cimino M, Shaha S, McDougal S, Pilliod J, Brodsky L. Risk reduction for adverse drug events through sequential implementation of patient safety initiatives in a children´s hospital. Pediatrics. 2006; 118: 124-9.

  53. Clarkson A, Ingleby E, Choonara I, Bryan P, Arlett P. A novel scheme for the reporting of adverse drug reactions. Arch Dis Child. 2001; 84: 337-9.

  54. Weiss J, Krebs S, Hoffman C, Werner U, Neubert A, Brune K, et al. Survey of adverse drug reactions on a pediatric ward: A strategy for early and detailed detection. Pediatrics. 2002; 110: 254-7.

  55. Sullivan JE, Buchino JJ. Medication errors in pediatrics-the octopus evading defeat. J Surg Oncol. 2004; 88: 182-8.

  56. Neubert A, Dormann H, Weiss J, Criegee-Rieck M, Ackermann A, Levy M, et al. Are computerized monitoring systems of value to improve pharmacovigilance in paediatric patients? Eur J Clin Pharmacol. 2006; 62: 959-65.

  57. Levy FH. Technology and pediatric patient safety: What to target is the dilemma? J Pediatr. 2008; 152: 153-5.




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